Interlab Corp

Summary Statement of Deficiencies D0000 A recertification survey conducted on 09/02/2020 to 09/04/2020 found that Interlab Corp clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to participate in American Association of Bioanalysts (AAB) proficiency testing (PT) for Routine Chemistry that resulted in a score of 0% for the third PT event in 2019 . Findings Included: A review of 2019 AAB proficiency testing revealed a score of 0% for Routine Chemistry along with the following analytes: Alanine Aminotransferase, albumin, amylase, Aspartate Aminotransferase, bilirubin total, Calcium total, cholesterol total, high-density lipoprotein. Creatine kinase total, creatinine total , glucose total , low-density lipoprotein, Magnesium, Potassium , sodium , total protein, Triglyceride, blood urea nitrogen and uric acid. During an interview on 09/04/20 at 12:30 PM, technologist A confirmed Routine Chemistry PT was not performed during the third event in 2019. D2100 ENDOCRINOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.843(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to participate in American Association of Bioanalysts (AAB) proficiency testing (PT) for Endocrinology that resulted in a score of 0% for the third PT event in 2019. Findings Included: A review of 2019 AAB proficiency testing revealed a score of 0% for Endocrinology with the following analytes: cortisol, Free Tyrosine, Human chorionic gonadotropin, thyroid function (T3 uptake), Thyroid-Stimulating Hormone, Tyrosine and triiodothyronine. During an interview on 09/04/20 at 12:30 PM, technologist A confirmed Endocrinology PT was not performed during the third event in 2019. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to keep documentation for the third proficiency testing (PT) event in 2018 from American Association of Bioanalysts (AAB). Findings Include: A review of AAB proficiency testing record revealed no documentation of PT records for the third testing event in 2018. During an interview on 09/04/20 at 12:30 PM, the technologist B confirmed that there was no documentation of PT records for the third testing event in 2018. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document and maintain a record of the open date, lot number and expiration date for Quik- Dip (QD) Stain for 2 years reviewed ( from 8/2018 to 8/2020). Findings Include: Record review of reagent log documentation for Histology section, revealed that there was no record of open date, lot number and expiration date for QD Stain reagents used from 8/2019 -- 2 of 3 -- to 9/2020. During an interview on 09/02/20 at 1:30 PM with the Cytology Supervisor, she confirmed that there was no documentation of the QD stain reagent lot and expiration dates. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on observation, record review and staff interview, the laboratory failed to follow their Quality assessment (QA) checklist and document when their AU680 Beckman Coulter instrument for chemistry was no longer in use due to flooding damage. Findings Included: A review of proficiency testing records revealed that AU680 Beckman Coulter instrument was performing chemistry testing from 2018 to June 22, 2020. A review of 2020 QA checklist displayed no documentation of the AU680 Beckman Coulter not in use during June 2020. An observation of the chemistry testing room revealed that there was no AU680 Beckman Coulter present or being used. During an interview on 09/04/20 at 12:30 PM, technologist B stated the AU680 Beckman Coulter was damaged and removed due to a flooding on June 25, 2020 and confirmed the instrument's removal was not documented in their QA checklist. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2019, the laboratory did not have successful performance in proficiency testing for the subspecialty of toxicology. Refer to D2118. Findings include: Review of the American Associates of Bioanalysts (AAB) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on January 16, 2020 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, phenytoin, for two out of three testing events in 2019. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the subspecialty of toxicology. Findings include: On January 16, 2020 on or about 10:00 AM the American Association of Bioanalysts (AAB) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, phenytoin, as shown below. Event #2, 2019 phenytoin-20% Event #3, 2019 phenytoin-0% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of toxicology. Findings include: On January 16, 2020, on or about 10:00 AM, the American Association of Bioanalysts (AAB) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, phenytoin, in the subspecialty of toxicology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2118. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for the analyte, phenytoin, in the sub specialty of toxicology. Findings Include: The review of the American Association of Bioanalysts (AAB) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on -- 2 of 3 -- January 16, 2020 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #2, 2019 phenytoin- 20 % Event #3, 2019 phenytoin-0%. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2018, the laboratory did not have successful performance in proficiency testing for the analytes, white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, and white blood cell differential, in the specialty of hematology. Refer to D2130. Findings include: Review of the American Associates of Bioanalysts (AAB) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on January 14, 2019 on or about 10:00 AM, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- showed that the laboratory had unsatisfactory testing scores for the analytes, white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, and white blood cell differential, , albumin for two out of three testing events in 2018. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful participation in proficiency testing for the analytes, white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, and white blood cell differential, in the specialty of hematology. Findings include: On January 14, 2019 on or about 10:00 AM the American Association of Bioanalysts (AAB) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analytes, white blood cell count (WBC), red blood cell count (RBC), hemoglobin (HGB), hematocrit (HCT), platelet count (PLT), and white blood cell differential (WBC Diff), as shown below. Event #2, 2018 WBC-0% RBC-0% HGB-0% HCT-0% PLT-0% WBC Diff-0% Event #3, 2018 WBC-0% RBC-0% HGB-0% HCT-0% PLT- 0% WBC Diff-0% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology. Findings include: On January 14, 2019, on or about 10:00 AM, the American Association of Bioanalysts (AAB) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory proficiency testing score for the analytes, white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, and white blood cell differential, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for the analytes, white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, and white blood cell differential, in the specialty of hematology. Findings Include: The review of the American Association of Bioanalysts (AAB) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on January 14, 2019 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #2, 2018 WBC-0% RBC-0% HGB-0% HCT-0% PLT-0% WBC Diff-0% Event #3, 2018 WBC-0% RBC-0% HGB-0% HCT-0% PLT-0% -- 3 of 3 --

Summary Statement of Deficiencies D0000 An onsite recertification and addition of specialty survey conducted on 7/2/2018 found Interlab Corp clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review for the histopathology specialty and interview with the Cytology Supervisor (CS), the laboratory failed to verify the accuracy of the histopathology testing twice a year from 10/2016 to 7/2018. Findings include: Review of proficiency testing records showed that there was no documentation of peer review from 9/2016 to 7/2018 for histopathology testing. During an interview on 7/2/2018 at 11:45 AM, the CS confirmed that the laboratory had not verified the accuracy of the interpretation of histopathology slides during the period of reference. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 CCR# 2018004322 A complaint survey was conducted on April 9, 2018.Interlab Corp was found not in compliance with 42 CFR 493, requirements for clinical laboratories. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation and the interview with the laboratory director, laboratory failed to provide adequate space, required storage, and ventilation system that would properly remove vapors, fumes and excessive heat for the Histopathology and Cytology subspecialty laboratory chemicals. Findings included: Observation on 4/9 /18 at 2:30 PM revealed that; (1) following chemicals, stains and reagents; A- Bouins Solution -Anapath, for tissue fixation ( label; formaldehyde, methanol, glacial acetic acid) Lot# 2065 Expiration date: 3/14 B- Papanicolaou Stain solution OG-6, Lot# 1705427, Expiration date: 3/2/18 C- 10% Formalin Fixative ( NBF) Lot# 1323809 Expiration date: 8/15. Gallon bottles- 2 D- Protocol Formalin Lot# 280479 Expiration date: 1/2018. E- Hydrochloric acid 1.0N 1L Lot# C380750 Expiration date: 2016/04 /30 F- Hydrochloric acid solution N/10 ( Normal/10) Lot# 130336 Expiration date: 02 /2015 G- Light Green Counter Stain REF STLGCPT Lot# 16110178 Expiration date: 2018/01/01 H- Solution in the glass bottle; had a label as Acid 5% Alcohol, with no date of preparation, expiration date or lot number. I- Ammonium Hydroxide 28% Lot# 1732014 Received date 1/16/18 (Label on bottle stated; Store locked up in well ventilated Space, but it was stored in regular cabinet under the counter top) J- Richard -Allan Scientific Clarifier-1, (label stated extremely flammable, was stored in regular cabinet) K- Cytoseal 60 Lot# 263527 Expiration date 7/2015 L- Methyl Alcohol; 1 gallon Lot# 275029 Expiration date 12/2015 M- Protocol Formalin - 1:10 Dilution ( Buffered) Lot# 280479 Expiration date 1/2018 Gallon bottles-3 N- Richard Allan Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- Scientific clarifier 1 gallon Lot# 275257 Expiration date 10/2015 O- 10% Formalin Fixative Lot# 1800411 Expiration date 1/18/2020, 8 Bottles, P- Platinum Line Xylenes- Mercedes Medical Lot# 1710706 10/20/2019 Q- White vinegar were observed in the laboratory; a) on top of the flammable storage cabinet, not in the flammable cabinet, b) in the regular cabinets, c) cabinets under the sink, d) on the floor in the laboratory and in the supply area, e) in the boxes on the floor, in a supply area with other storage cabinets, file cabinets, regular office supplies, slide storage, other storage cabinets and other supplies on shelves,leaving no adequate room to reach out for the chemicals or other supplies, and with no ventilation. There was a strong chemical smell on the floor where the laboratory was located and the smell continued throughout the laboratory during the time of the complaint investigation. There were no records of MSDS for the laboratory chemicals, stains, and reagents for chemical hazard, storage and handling at the time of complaint investigation. There were no records of OSHA ( occupational safety and health administration ) regulations and training at the time of complaint investigation. (2) f) FUMEGARD - activated carbon fume removal filter- date installed; 9/9/16 on the sticker, not functional. g) SHANDON -- activated carbon fume removal filter- date installed; 9/9 /16 on the sticker, functional, was not turned on- 4/9/18. h) FUMEGARD-no sticker as when was installed, functional, was not turned on- 4/9/18 i) Surgipath XYL -X50B air filter, no sticker to show when was installed, functional, was turned on -4/9/18. Laboratory did not have any maintenance records for the histology section fume hood air filters from 9/9/16 to 4/9/18. (3) Flammable storage cabinet had hazardous chemicals, expired, not part of the laboratory, not labeled as not part of the laboratory. Interview with Histopathology and Cytology subspecialty laboratory director at about 4:45 PM, confirmed findings (1), (2) and (3). D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, record review and the interview with the laboratory director, Histopathology and Cytology subspecialty laboratory failed to establish, access and observe safety procedures to provide the safety and sanitary conditions to the personnel. Findings included: Observation on 4/9/18 at 2:30 PM revealed that; (1) following chemicals, stains and reagents; A- Bouins Solution -Anapath, for tissue fixation ( label; formaldehyde, methanol, glacial acetic acid) Lot# 2065 Expiration date: 3/14 B- Papanicolaou Stain solution OG-6, Lot# 1705427, Expiration date: 3/2 /18 C- 10% Formalin Fixative ( NBF) Lot# 1323809 Expiration date: 8/15. Gallon bottles- 2 D- Protocol Formalin Lot# 280479 Expiration date: 1/2018. E- Hydrochloric acid 1.0N 1L Lot# C380750 Expiration date: 2016/04/30 F- Hydrochloric acid solution N/10 ( Normal/10) Lot# 130336 Expiration date: 02/2015 G- Light Green Counter Stain REF STLGCPT Lot# 16110178 Expiration date: 2018 /01/01 H- Solution in the glass bottle; had a label as Acid 5% Alcohol, with no date of preparation, expiration date or lot number. I- Ammonium Hydroxide 28% Lot# 1732014 Received date 1/16/18 (Label on bottle stated; Store locked up in well ventilated Space, but it was stored in regular cabinet under the counter top) J- Richard -Allan Scientific Clarifier-1, (label stated extremely flammable, was stored in regular cabinet) K- Cytoseal 60 Lot# 263527 Expiration date 7/2015 L- Methyl Alcohol; 1 -- 2 of 7 -- gallon Lot# 275029 Expiration date 12/2015 M- Protocol Formalin - 1:10 Dilution ( Buffered) Lot# 280479 Expiration date 1/2018 Gallon bottles-3 N- Richard Allan Scientific clarifier 1 gallon Lot# 275257 Expiration date 10/2015 O- 10% Formalin Fixative Lot# 1800411 Expiration date 1/18/2020, 8 Bottles, P- Platinum Line Xylenes- Mercedes Medical Lot# 1710706 10/20/2019 Q- White vinegar were observed in the laboratory; a) on top of the flammable storage cabinet, not in the flammable cabinet, b) in the regular cabinets, c) cabinets under the sink, d) on the floor in the laboratory and in the supply area, e) in the boxes on the floor, in a supply area with other storage cabinets, file cabinets, regular office supplies, slide storage other storage cabinets and other supplies on shelves,leaving no adequate room to reach out for the chemicals or other supplies, and with no ventilation. There was a strong chemical smell on the floor where the laboratory was located and the smell continued throughout the laboratory during the time of the complaint investigation. There were no records of MSDS for the laboratory chemicals and reagents for chemical hazard, storage and handling at the time of complaint investigation. (2) f) FUMEGARD - activated carbon fume removal filter- date installed; 9/9/16 on the sticker, not functional. g) SHANDON -- activated carbon fume removal filter- date installed; 9/9/16 on the sticker, functional, was not turned on- 4/9/18. h) FUMEGARD-no sticker as when was installed, functional, was not turned on- 4/9/18 i) Surgipath XYL -X50B air filter, no sticker to show when was installed, functional, was turned on -4/9/18. Laboratory did not have any maintenance records for the histology section fume hood air filters from 9/9/16 to 4/9/18. (3) Flammable storage cabinet had hazardous chemicals, expired, not part of the laboratory, not labeled as not part of the laboratory. (4) No liquid soap in the liquid soap bottle for hand wash in the laboratory. (5) No safety goggles in the laboratory. Interview with Histopathology and Cytology subspecialty laboratory director at about 4:45 PM, confirmed findings (1), (2), (3), (4) and (5). D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on the test requisition form and the final report review, laboratory failed to document the correct collection date on the final report for hrHPV-DNA (high-risk Human Papilloma Virus- Deoxyribonucleic acid) test. Findings included: Requisition form and report for patient #2, case surveyor selected for review on 4/9/18, reviewed on 4/10/18 had date collected as 3/29/18 on the test requisition form and date collected as 3/30/18 on final test report for hrHPV-DNA (high-risk Human Papilloma Virus- Deoxyribonucleic acid) test As the cytology supervisor had to go for the day on 4/9/18, laboratory had provided the patient's test reports later via e-mail on 4/10/18, there was no interview with the supervisor. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of